MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 170706-1

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

As reported: "products 170706-1 were ordered and what is listed on the packaging but products 170604 lot code 26080916 were what was inside the packaging.".

Event Description

As reported: "products 170706-1 were ordered and what is listed on the packaging but products 170604 lot code 26080916 were what was inside the packaging.".

Manufacturer Narrative

An event regarding product mix involving a mako baseplate trial was reported.The event was confirmed.The products were returned with the packaging.Two baseplate trials were returned, catalog: 170604, lot: 26080916.The trials were in new condition.Both baseplate trials had catalog #170604 on device with package labels for insert trials, catalog: 170706-1, lot number: 12371116.Medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.There has been 7 other events for the lot indicated.The investigation confirmed the reported event of a product mix between the trial baseplate and trial insert.Nc was issued on for the product mix.The nc determined the root cause of this event was a lack of standard work where personnel did not perform proper line clearance due to a lack of training.

• Brand Name: TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7309516
• MDR Text Key: 101433833
• Report Number: 3005985723-2018-00105
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170706-1
• Device Lot Number: 12371116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other